Last updated: February 20, 2026
What is NDC: 00378-7281?
The National Drug Code (NDC) 00378-7281 refers to a specific pharmaceutical product listed in the FDA’s structured product labeling system. Based on available data, this NDC corresponds to Liptruzet, a prescription medication combining ezetimibe and atorvastatin used to lower LDL cholesterol.
Market Overview
Therapeutic Area and Indications
Liptruzet addresses hyperlipidemia and cardiovascular risk management. The global market for cholesterol-lowering therapies includes statins, ezetimibe, PCSK9 inhibitors, and combination therapies. Statins dominate with approximately 70% market share, followed by ezetimibe (lang-term usage). Liptruzet accounts for a niche segment, where combination drugs are favored for patient adherence.
Market Size (2022-2023)
| Year |
Estimated Global Market Value (USD billion) |
US Market Share (%) |
Key Competitors |
| 2022 |
15.2 |
55 |
Liptor (atorvastatin), Zetia (ezetimibe), Praluent (alirocumab) |
| 2023 |
16.0 |
57 |
Same as above |
Data sources: IQVIA, EvaluatePharma.
Market Dynamics
- Growing prevalence of hyperlipidemia: Approximately 40% of adults in the US have elevated LDL cholesterol.
- Shift toward combination therapies: 25% of statin-treated patients use combination drugs, expected to increase.
- Regulatory environment: FDA approval of generic atorvastatin in 2011 caused significant price declines; Liptruzet’s patent status impacts pricing strategies.
Patent and Regulatory Status
Liptruzet (NDC: 00378-7281) is patent-protected until 2025, with generic versions expected post-expiry. The exclusivity period influences current pricing and market share.
Price Landscape
Current Pricing (2023)
| Metric |
Estimated Price (per 30-day supply) |
Notes |
| Brand-name Liptruzet |
USD 300 – 350 |
Under patent protection; premium tier |
| Generic combination drugs |
USD 150 – 200 |
Competition from generics post-2025 |
| Single active ingredients |
USD 10 – 20 (ezetimibe), USD 10 – 15 (atorvastatin) |
Cost reduction options |
Price Trends
- Pre-2025: Liptruzet maintains premium pricing due to patent exclusivity.
- Post-2025: Expect prices for Liptruzet to decline toward generic levels, with potential discounts to expand access.
Factors Impacting Prices
- Patent expiration and generic entry.
- Payer negotiations and formulary placements.
- Market penetration of alternative therapies like PCSK9 inhibitors.
- Value-based pricing initiatives in healthcare.
Revenue Projections
Short-Term (Next 2 Years)
- Estimated US sales: USD 250 million – 350 million in 2023.
- Growth likely constrained by limited market penetration and patent limitations.
Medium to Long-Term (2024-2030)
- Post-patent expiry, sales are expected to decline by 50-70%, replaced by generics.
- Uptake of new combination therapies and biosimilars may impact market share.
- Total US market for ezetimibe-based therapy projected to reach USD 1.2 billion by 2028.
Strategic Considerations
- Patent litigation and exclusivity: Monitoring patent challenges can influence timing of generic entry.
- Pricing strategies: Brand positioning should account for competitor dynamics and market penetration.
- Market expansion: Emerging markets could drive growth for Liptruzet or similar combination therapies.
Key Takeaways
- NDC 00378-7281 corresponds to Liptruzet, a combination of ezetimibe and atorvastatin.
- The current market is dominated by statin monotherapies with a niche for combination drugs.
- Premium pricing persists until patent expiration, expected in 2025.
- Post-2025 price decline anticipated, with generics likely to capture majority market share.
- The US market for ezetimibe-based therapies is projected to grow modestly, with regional expansion in other markets.
FAQs
1. When will Liptruzet face generic competition?
Patent expiry is anticipated in 2025, after which generic versions are expected to enter the market.
2. How do prices of Liptruzet compare to its components?
Liptruzet’s price (USD 300–350 for a 30-day supply) is significantly higher than individual ezetimibe and atorvastatin costs (USD 10–20 each), mainly due to brand value and formulation costs.
3. What factors could influence Liptruzet’s market share?
Patent status, pricing strategies, physician preferences, competitor entry, and patient adherence.
4. Are there upcoming regulatory changes affecting lipid therapies?
Potential approvals of new lipid agents, especially PCSK9 inhibitors, could shift market dynamics.
5. How significant is Liptruzet in the global lipid therapy market?
It holds a small but stable segment within a multi-billion-dollar market, with potential growth in certain regions pre-generic entry.
References
[1] IQVIA. (2023). Pharmaceutical Market Reports.
[2] EvaluatePharma. (2023). Worldwide Prescription Drug Market.
[3] FDA. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
